Interbody device and plate for spinal stabilization and instruments for positioning same

ABSTRACT

Systems, methods and devices for providing stabilization between first and second vertebrae are provided. More particularly, in one form a system includes an implant configured to be positioned in a disc space between the first and second vertebrae and a freestanding plate for engagement with extradiscal surfaces of the first and second vertebrae. The system also includes an insertion instrument with an engaging portion configured to releasably engage with the implant and the plate such that the implant and plate can be positioned together relative to the first and second vertebrae. In one aspect, an angular orientation of the implant relative to the plate is adjustable when the implant and the plate are engaged by the instrument. In this or another aspect, the implant and plate are held in a contiguous relationship when engaged by the instrument. However, different forms and applications are also envisioned.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 14/854,693,filed on Sep. 15, 2015, which is a continuation of application Ser. No.14/175,014, filed on Feb. 7, 2014, now U.S. Pat. No. 9,180,019, which isa continuation of application Ser. No. 13/858,351, filed on Apr. 8,2013, now U.S. Pat. No. 8,690,948, which is a continuation ofapplication Ser. No. 13/040,035, filed on Mar. 3, 2011, now U.S. Pat.No. 8,454,694. The contents of these prior applications are hereinincorporated by reference, in their entireties.

BACKGROUND

The present application relates generally to spinal stabilizationinvolving an interbody implant device and related support plate, and toinstruments and methods for inserting and positioning the device and theplate together relative to the spinal column.

Several techniques and systems have been developed for correcting andstabilizing the spine and for facilitating fusion at various levels ofthe spine. Some of these include positioning one or more interbodyimplants in a spinal disc space between adjacent vertebrae. When animplant is placed into a disc space, the channel or path that theimplant took to enter the disc space provides a path for retrogrademovement of the implant from the disc space. In some forms, a plate canbe used to prevent retrograde movement of the implant and/or to provideadditional stability to the adjacent vertebrae. If used, the plate isoften positioned into engagement with the adjacent vertebrae in aseparate surgical step that follows implantation of the implant. Theimplant can also be attached to the plate prior to implantation,although such attachment can limit adjustability of the implant andplate relative to one another to accommodate for various aspects of thespinal anatomy of the vertebrae and/or increase the length andcomplexity of the surgical procedure.

Thus, there remains a need for further improvements in spinalstabilization involving an interbody implant device and related supportplate, and in the instruments and methods for inserting and positioningthe same.

SUMMARY

Interbody implants and related support plates for spinal stabilization,as well as instruments and techniques for inserting and positioning animplant and plate together relative to the spinal column, are provided.More particularly, in one form a system includes an implant configuredto be positioned in a disc space between the first and second vertebraeand a freestanding plate for engagement with the first and secondvertebrae. The system also includes an insertion instrument with anengaging portion configured to releasably engage with the implant andthe plate such that the implant and plate can be positioned togetherrelative to the first and second vertebrae in a single surgical step. Inone aspect, an angular orientation of the implant relative to the plateis adjustable when the implant and the plate are engaged by theinstrument. In this or another aspect, the implant and plate are held ina contiguous relationship when engaged by the instrument. However,different forms and applications are also envisioned.

In one embodiment, a system for providing spinal stabilization includesan implant including a body extending from a leading end to an oppositetrailing end. The body further includes a superior bone engaging surfaceand an opposite inferior bone engaging surface, with the superior andinferior bone engaging surfaces engaging respective endplates of upperand lower vertebrae when the implant is positioned in a spinal discspace between the upper and lower vertebrae. The system also includes aplate for engagement with the upper and lower vertebrae. The plateincludes a body extending between an upper end and an opposite lowerend, and the plate body includes a top surface and an opposite bottomsurface facing the upper and lower vertebrae when the plate is engagedtherewith. An insertion instrument includes an engaging portionconfigured to releasably engage with the implant and the plate such thatan angular orientation of the implant relative to the plate isadjustable when the implant and the plate are engaged by the instrument.

In another embodiment, a system for providing spinal stabilizationincludes an implant including a body extending from a leading end to anopposite trailing end. The body further includes a superior boneengaging surface and an opposite inferior bone engaging surface, withthe superior and inferior bone engaging surfaces engaging respectiveendplates of upper and lower vertebrae when the implant is positioned ina spinal disc space between the upper and lower vertebrae. The systemalso includes a plate for engagement with the upper and lower vertebraeand including a body extending between an upper end and an oppositelower end. The plate body further includes a proximal surface, anopposite distal surface, and a distal facing intermediate portionconfigured to cooperate with the trailing end of the implant. Aninsertion instrument includes an engaging portion configured toreleasably engage with the implant and the plate such that the implantand the plate are held in a contiguous relationship when engaged by theinstrument and the implant is displaceable from the plate upondisengagement of the instrument.

In still another embodiment, a method for providing spinal stabilizationbetween first and second vertebrae includes providing an implantincluding a body extending from a leading end to an opposite trailingend, with the body also including a superior bone engaging surface andan opposite inferior bone engaging surface. The method also includesproviding a plate for engagement with the first and second vertebrae.The plate includes a body extending between an upper end and an oppositelower end. Further steps of the method include engaging an insertioninstrument with the implant and the plate, which includes retaining theimplant and the plate in a contiguous, uncoupled arrangement; andinserting the leading end of the implant in a spinal disc space betweenthe first and second vertebrae with the insertion instrument andadvancing the implant into the disc space until a bottom surface of theplate contacts extradiscal surfaces of the first and second vertebrae. Afurther aspect of this embodiment includes rotating the implant relativeto the plate when the insertion instrument is engaged with the implantand the plate and the implant and the plate are retained in thecontiguous, uncoupled arrangement. Still, another aspect of thisembodiment includes guiding at least one fastener along a correspondingguide hole through the insertion instrument and the plate intoengagement with one of the vertebrae.

Other embodiments include unique methods, techniques, systems, devices,kits, assemblies, equipment, and/or apparatus for use in connection withthe stabilization and support of first and second vertebrae. However, inother embodiments, different forms and applications are also envisioned.

Further embodiments, forms, features, aspects, benefits, objects andadvantages of the present application will become apparent from thedetailed description and figures provided herewith.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a diagrammatic plan view, with some features being shown insection, looking toward the axial plane of an endplate of a vertebralbody of a spinal column with an interbody implant and plate positionedrelative thereto.

FIG. 2 is a diagrammatic elevation view looking toward the sagittalplane at a vertebral level of the spinal column including the vertebralbody, interbody implant and plate of FIG. 1.

FIG. 3 is a top, plan view of the interbody implant illustrated in FIG.1.

FIG. 4 is a side, plan view of the interbody implant illustrated in FIG.1.

FIGS. 4A and 4B are side, plan views of alternative embodiment interbodyimplants.

FIG. 5 is a perspective view of the interbody implant illustrated inFIG. 1.

FIG. 6 is a front, plan view of the plate illustrated in FIG. 1.

FIGS. 7 and 8 are opposite, side plan views of the plate illustrated inFIG. 1.

FIG. 9 is a plan view of one embodiment insertion instrument configuredto insert and position the interbody implant and plate of FIG. 1relative to the spinal column.

FIG. 10 is a plan view of the insertion instrument illustrated in FIG. 9rotated ninety degrees about its longitudinal axis.

FIG. 11 is a plan view of the distal end of the instrument illustratedin FIG. 9 rotated one hundred and eighty degrees about its longitudinalaxis.

FIG. 12 is section view of the proximal end of the instrumentillustrated in FIG. 9 taken along view line 12-12.

FIG. 13 is a plan view of an inner member of the instrument illustratedin FIG. 9.

FIG. 14 is a section view of the inner member illustrated in FIG. 13taken along view line 14-14.

FIG. 15 is a perspective view of the distal end of the inner memberillustrated in FIG. 13.

FIG. 16 is a plan view of an outer member of the instrument illustratedin FIG. 9.

FIG. 17 is a section view of the outer member illustrated in FIG. 16taken along view line 17-17.

FIG. 18 is a plan view of the instrument illustrated in FIG. 9 engagedwith the interbody implant and plate of FIG. 1.

FIG. 19 is a plan view of an alternative embodiment insertion instrumentconfigured to insert and position the interbody implant and plate ofFIG. 1 relative to the spinal column.

FIG. 20 is a plan view of the insertion instrument illustrated in FIG.19 rotated ninety degrees about its longitudinal axis and with somefeatures being shown in section along view line 20-20.

DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended. Any such alterations and furthermodifications in the illustrated devices and described methods, and anysuch further applications of the principles of the invention asillustrated herein are contemplated as would normally occur to oneskilled in the art to which the invention relates.

Methods, techniques, instrumentation, devices and implants are providedto restore and/or maintain a collapsed, partially collapsed, damaged,diseased, or otherwise impaired spinal disc space at a desired discspace height and adjacent endplate orientation. The instruments andimplants may be used in techniques employing minimally invasiveinstruments and technology to access the disc space, although access innon-minimally invasive procedures is also contemplated. Access to thecollapsed disc space can be uni-portal, bi-portal, or multi-portal. Theinstruments and implants may also be employed in a direct anteriorapproach to the spinal disc space, although other approaches are alsocontemplated, including lateral, antero-lateral, postero-lateral,oblique, and posterior approaches. Also, the surgical methods,techniques, instruments and implants may find application at allvertebral segments of the spine, including the lumbar, thoracic andcervical spinal regions.

In one aspect, interbody implants and related support plates for spinalstabilization, as well as instruments and techniques for inserting andpositioning an implant and plate together relative to the spinal column,are provided. More particularly, in one form a system includes animplant configured to be positioned in a disc space between the firstand second vertebrae and a freestanding plate for engagement with thefirst and second vertebrae. The system also includes an insertioninstrument with an engaging portion configured to releasably engage withthe implant and the plate such that the implant and plate can bepositioned together relative to the first and second vertebrae in asingle surgical step. In one aspect, an angular orientation of theimplant relative to the plate is adjustable when the implant and theplate are engaged by the instrument. In this or another aspect, theimplant and plate are held in a contiguous relationship when engaged bythe instrument. However, different forms and applications are alsoenvisioned.

Referring now generally to FIG. 1, it illustrates a plan view, with somefeatures being shown in section, looking caudally toward the axial planeof a vertebral body V1. As illustrated in FIGS. 1 and 2, spinalinterbody implant 10 is positioned on the vertebral endplate E1intradiscally between vertebral bodies V1, V2, and a plate 12 is securedsubstantially extradiscally, or outside the disc space, to vertebralbodies V1, V2 with a plurality of bone engaging fasteners, two of whichare shown in the form of bone screws 14, 16. In the illustrated form, aportion of plate 12 also extends between vertebral bodies V1, V2,although forms in which plate 12 is positioned entirely extradiscallywith no portion of it extending between vertebral bodies V1, V2 are alsocontemplated. Vertebral body V1 along with vertebral body V2 and spinaldisc space D comprise a level of spinal column segment SC in thecervical region, although implantation of implant 10 and plate 12 in thethoracic and lumbar regions is also possible and contemplated, asindicated above. Implant 10 is positioned in disc space D betweenvertebral bodies V1 and V2 so that when it is in its implantedorientation it contacts endplates E1 and E2. In the illustrated form,plate 12 is positioned so that it lies along the anterior facingsurfaces of vertebral bodies V1, V2, although positioning of plate 12along alternatively facing surfaces of vertebral bodies V1, V2 dependingon the orientation of implant 10 to vertebral bodies V1, V2 is alsocontemplated. Similarly, in the illustrated form vertebral bodies V1, V2are accessed from an anterior approach, although lateral,antero-lateral, postero-lateral, oblique, and posterior approaches arealso possible. Further, as illustrated, implant 10 and plate 12 aregenerally positioned adjacent to and in abutting engagement with oneanother, although it should be appreciated that movement of implant 10away from plate 12 is possible since implant 10 and plate 12 are notphysically attached or otherwise coupled to one another as will bediscussed in greater detail below.

Referring now generally to FIGS. 3-5, implant 10 includes a body 18sized to fit within the disc space D between adjacent vertebral bodiesV1, V2. Body 18 extends from a leading end 20 to an opposite trailingend 22. In the illustrated form, leading end 20 generally includes aplanar surface 24 positioned between angled surfaces 26, 28 which canfacilitate insertion of implant 10 into disc space D and/or distractionof vertebral bodies V1, V2. In other non-illustrated forms, leading end20 can include a convexly rounded nose to facilitate insertion into discspace D and distraction of vertebral bodies V1, V2. As illustrated inFIG. 3 for example, body 18 also includes a receptacle 23 in which aradiographic marker can be positioned to facilitate image-guidedplacement of implant 10 between vertebral bodies V1, V2.

Body 18 also includes superior and inferior bone engaging surfaces 30,32 with ridges 34, 36 (only a few of which are referenced to preserveclarity) to enhance engagement with the vertebral end plates E1, E2. Inother forms, superior and inferior bone engaging surfaces 30, 32 can beprovided with threads, grooves, teeth knurling or other surfaceroughening, just to provide a few possibilities, to enhance engagementwith vertebral endplates E1, E2. In the illustrated form, bone engagingsurface 30 includes a generally convex configuration between leading end20 and trailing end 22, while bone engaging surface 32 includes agenerally planar or straight configuration between leading end 20 andtrailing end 22. In other forms, it should be appreciated that boneengaging surface 30 could also be planar and that bone engaging surface32 could also be convexly curved. Still, other variations in theconfigurations of bone engaging surfaces 30, 32 between leading end 20and trailing end 22 are possible. Further, bone engaging surfaces 30, 32are generally configured such that implant 10 is received between and incontact with at least a portion of endplates E1, E2 along at least aportion of body 18. Body 18 also includes opposite side walls 38, 40extending from leading 20 to trailing end 22, and also extending frombone engaging surface 30 to bone engaging surface 32. Side walls 38, 40can be parallel to one another, or tapered relative to one another toconverge or diverge toward the leading end 20. Side walls 38, 40 can beplanar, concave or convex from leading end 20 to trailing end 22,concave or convex from bone engaging surface 30 to bone engaging surface32, or combinations thereof.

Body 18 also includes a cavity 42 that opens through bone engagingsurfaces 30, 32 to facilitate bone growth through body 18, althoughforms where cavity 42 is not present are also possible. In othernon-illustrated forms, it is contemplated that body 18 could alsoinclude one or more openings extending through side walls 38, 40 and/orleading and trailing ends 20, 22 and into communication with cavity 42.In addition, while not illustrated, it should be appreciated that one ormore biocompatible materials which, for example, provide a therapeuticeffect or enhance bone growth through implant 10 can be positioned incavity 42. Examples of such biocompatible materials may include calciumphosphate, hyrdroxyapatite-tricalcium phosphate (HA-TCP) compounds,bioactive glasses, calcium sulfate bone void fillers, collagen, fibrin,albumin, karatin, silk, elastin, demineralized bone matrix, particulatebone, mysenchymal stem cells, hormones, growth factors such astransforming growth factor beta (TGFb) proteins, bone morphogenicproteins (including BMP and BMP2), or platelet derived growth factors,just to provide a few possibilities. In one aspect, the biocompatiblematerial(s) may, when included, extend slightly above and below boneengaging surfaces 30, 32, respectively, to facilitate compressiveloading by the adjacent vertebral bodies onto and through thebiocompatible material(s).

As illustrated in FIG. 4 for example, trailing end 22 of implant 10 isgenerally convexly curved between bone engaging surfaces 30, 32. Inaddition, trailing end 22 also includes an elongate slot 44 that ispositioned between bone engaging surfaces 30, 32 and extends betweenside walls 38, 40, although in other forms it should be appreciated thattrailing end 22 can be provided without elongate slot 14. Body 18 alsoincludes a first receptacle 46 formed in side wall 38 and generallyincluding a circular arrangement configured to receive a correspondinglyconfigured portion of an insertion instrument, further details of whichwill be provided below. Body 18 also includes a notch or groove 47formed in side wall 38. Groove 47 includes upper and lower surfaces 48,50 and lateral facing surfaces 52, 54, and extends through trailing end22 into communication with first receptacle 46. In the illustrated form,upper and lower surfaces 48, 50 are generally arranged in an obliqueorientation relative to one another, although other forms arecontemplated. Body 18 also includes a second receptacle 56 formed inside wall 40 and generally including a circular arrangement configuredto receive a correspondingly configured portion of an insertioninstrument, further details of which will be provided below. Body 18also includes a notch or groove 57 formed in side wall 40. Groove 57includes upper and lower surfaces 58, 60 and lateral facing surfaces 62,64, and extends through trailing end 22 into communication with secondreceptacle 56. In the illustrated form, upper and lower surfaces 58, 60are generally arranged in an oblique orientation relative to oneanother, although other forms are contemplated.

While not previously discussed, it should be appreciated that thegenerally circular arrangement of receptacles 46, 56 which allowsreceipt of a correspondingly configured portion of the insertioninstrument allows an angular orientation of implant 10 relative to plate12 to be adjusted when implant 10 and plate 12 are engaged by theinsertion instrument, further details of which will be provided below.However, it should be appreciated that other configurations of implant10 are possible for allowing the angular orientation of implant 10relative to plate 12 to be adjusted when implant 10 and plate 12 areengaged by the insertion instrument. For example, with reference to FIG.4A, elongate slot 44 and grooves 47, 57 have been omitted fromalternative embodiment implant 10 a. In addition, receptacle 46 a isgenerally configured as an elongated slot configured to receive a roundfeature of the insertion instrument in order to hold implant 10 a withthe instrument while also allowing adjustment of the angular orientationof implant 10 a relative to plate 12 and the insertion instrument whenimplant 10 a and plate 12 are engaged by the insertion instrument. Asanother example, FIG. 4B illustrates another alternative embodimentimplant 10 b from which elongate slot 44 and grooves 47, 57 have beenomitted. Implant 10 b includes a receptacle 46 b in the form of anarcuately shaped slot configured to receive a round feature of theinsertion instrument in order to hold implant 10 b with the instrumentwhile also allowing adjustment of the angular orientation of implant 10b relative to plate 12 and the insertion instrument when implant 10 band plate 12 are engaged by the insertion instrument. While not shown inFIGS. 4A and 4B, it should be appreciated that the receptaclespositioned opposite of receptacles 46 a, 46 b are configured the same asreceptacles 46 a, 46 b. In addition, it should also be appreciated thatother than the differences described above, implants 10 a, 10 b willgenerally be configured the same as implant 10.

Further details regarding plate 12 are shown in FIGS. 6-8. Plate 12includes a body 66 that extends along a central axis 68 that is orientedto extend generally along the central axis of the spinal column SC andfrom vertebral body V1 to vertebral body V2 when plate 12 is implanted.In the illustrated form, body 66 generally includes a substantiallysquare configuration, although forms in which body 66 is elongated alongcentral axis 68 and includes a rectangular, oval or elliptical shape,just to provide a few examples, are also contemplated. Body 66 includesan upper or cephalad end 70 and an opposite lower or caudal end 72, andopposite side surfaces 74, 76 that extend between ends 70, 72. Body 66also includes superior bone screw holes 78, 80 adjacent upper end 70 andinferior bone screw holes 82, 84 adjacent lower end 72. Bone screw holes78, 80 and 82, 84 extend through and open at top surface 86 and bottomsurface 88 of body 66, and are generally arranged to allow bone screwsto extend obliquely through and away from body 66. More particularly,bone screw holes 78, 80 are generally arranged to allow bone screwsextending therethrough to extend obliquely to plate 12 in a lateral,cephalad direction, while bone screw holes 82, 84 are generally arrangedto allow bone screws extending therethrough to extend obliquely to plate12 in a lateral, caudal direction. Among other things, the orientationof bone screw holes 78, 80 and 82, 84 in this arrangement allows the useof relatively longer bone screws, resulting in better engagement andpurchase with the adjacent vertebral bodies. Further, in thisarrangement, the trajectories of bone screw holes 78, 80 and 82, 84extend toward a common location above plate 12 such that the operatingspace necessary for inserting screws through plate 12 is reduced,thereby minimizing the impact to the surrounding patient anatomy. Inother non-illustrated forms, it should be appreciated that plate 12 canbe provided with one bone screw hole or more than two bone screw holesadjacent each of upper end 70 and lower end 72.

Body 66 also includes a retaining element 86 which can be secured tobody 66 with a threaded shaft, clip or other configuration that allowsretaining element 86 to rotate while attached to body 66. Retainingelement 86 includes a cross-like configuration including ends 86 a-d anda central driving tool receptacle 88. For the sake of clarity, it shouldbe appreciated that retaining element 86 has been omitted from body 66in FIGS. 7-8. The retaining element 86 also includes concavely curvedsidewall portions 90 a-b that can be aligned simultaneously with therespective adjacent bone screw hole 78, 80, 82, 84 to allow insertion ofa bone screw and its proximal head into the adjacent bone screw hole 78,80, 82, 84. When the bone screw heads are seated in bone screw holes 78,80, 82, 84, retaining element 86 can be rotated so that ends 86 a-doverlap the respective bone screw hole 78, 80, 82, 84 and block orcontact the bone screw head to prevent bone screw back-out from bonescrew holes 78, 80, 82, 84. It should also be appreciated that othershapes and designs of retaining element 86 are possible for preventingbone screw back-out from screw holes 78, 80, 82, 84. For example, in onenon-illustrated form, retaining element 86 can be in the form of athreaded fastener which is engaged with plate 12 after it is attached tovertebral bodies V1, V2 such that at least a portion of an enlarged headof the threaded fastener extends over screw holes 78, 80, 82, 84.

Body 66 of plate 12 also includes grooves 92, 94 that extend into sidesurfaces 74, 76 and from top surface 86 to bottom surface 88. Asillustrated in FIG. 7, groove 92 includes a receptacle 96 that generallyhas a racetrack shaped configuration. More particularly, receptacle 96includes parallel sides between which extend arcuate or rounded endportions. As illustrated in FIG. 8, groove 94 includes a receptacle 98that also generally has a racetrack shaped configuration. In othernon-illustrated forms, it should be appreciated that otherconfigurations, including oval or polygonal to provide a fewpossibilities, are also contemplated. Receptacles 96, 98 are configuredto receive correspondingly configured portions of an insertioninstrument, further details of which will be provided below.

In addition, body 66 also includes an intermediate portion 100 thatincludes a concavely shaped surface 102 facing away from top surface 86.Surface 102 is generally configured to cooperate with trailing end 22 ofimplant 10 when implant 10 and plate 12 are positioned adjacent to oneanother. Intermediate portion 100 extends away from top surface 86 suchthat surface 102 is offset away from top surface 86 relative to upperand lower portions 104, 106 of bottom surface 88. Similarly, asillustrated in FIG. 2 for example, this arrangement results in surface102 and at least a portion of intermediate portion 100 being positionedin disc space D between vertebral bodies V1, V2 when upper and lowerportions 104, 106 of bottom surface 88 contact vertebral bodies V1, V2and plate 12 is engaged with vertebral bodies V1, V2. In othernon-illustrated forms however, it should be appreciated that surface 102can be aligned with upper and lower portions 104, 106 of bottom surface88 or offset toward top surface 86 relative to upper and lower portions104, 106 of bottom surface 88 such that no portion of plate 12 extendsinto disc space D when it is engaged with vertebral bodies V1, V2. Inother non-illustrated forms, surface 102 can be flat or include a convexshape that is configured to cooperate with implant 10 having a concavetrailing end 22.

Referring now generally to FIGS. 9-17, further details regarding aninsertion instrument 120 configured to engage with implant 10 and plate12 and position implant 10 and plate 12 relative to vertebral bodies V1,V2 will be provided. Instrument 120 extends along longitudinal axis Lfrom proximal end 122 to distal end 124 and includes an inner member126, outer member 128 and a drive member 130. Inner member 126 extendsbetween a threaded proximal portion 132 and a distal engaging portion134. Distal engaging portion 134 is bifurcated into portions 148, 150which surround a hollow interior 160 and from which tines 136, 138extend. Portions 148, 150 also include tapered surfaces 162, 164adjacent the proximal ends of tines 136, 138, and are pivotable aboutpassage 158 such that tines 136, 138 can be moved relative to oneanother to facilitate engagement and disengagement of instrument 120with implant 10 and plate 12. While not illustrated, it should beappreciated that a spring or other resiliently elastic material, such asa rubber plug, can be positioned in passage 158 such that tines 136, 138are normally biased away from one another. Tine 136 includes a distal,generally circular shaped projection 140 configured to be positioned inreceptacle 46 of implant 10. Tine 136 also includes a generallyracetrack shaped projection 142 proximally spaced from projection 140and configured to be positioned in receptacle 96 of plate 12. Tine 136is further configured to be positioned in groove 47 of implant 10 andgroove 92 of plate 12 when instrument 120 is engaged with implant 10 andplate 12. Tine 138 includes a distal, generally circular shapedprojection 144 configured to be positioned in receptacle 56 of implant10. Tine 138 also includes a generally racetrack shaped projection 146proximally spaced from projection 144 and configured to be positioned inreceptacle 98 of plate 12. Tine 138 is further configured to bepositioned in groove 57 of implant 10 and groove 94 of plate 12 wheninstrument 120 is engaged with implant 10 and plate 12. Inner member 126also includes an opening 152 that extends obliquely to longitudinal axisL and into communication with hollow interior 160. Another set ofopenings 154, 156 are positioned opposite of opening 152 and extendobliquely to longitudinal axis L and into communication with hollowinterior 160.

Outer member 128 extends between proximal end 170 and distal end 172 andincludes a hollow interior 174 which receives inner member 126. Outermember 128 also includes an opening 176 that extends obliquely tolongitudinal axis L and into communication with hollow interior 174. Aridge 177 extends along a portion of opening 176 and defines oppositeportions 176 a, 176 b of opening 176. Another set of openings 178, 180(FIG. 11) are positioned opposite of opening 176 and extend obliquely tolongitudinal axis L and into communication with hollow interior 174.When inner member 126 is positioned in outer member 128 and instrument120 engages with implant 10 and plate 12, opening 176 of outer member128 generally aligns with opening 152 of inner member 126 and openings178, 180 of outer member 128 generally align with openings 154, 156 ofinner member 126. Similarly, in this arrangement, cooperation ofopenings 152, 176 allows placement of bone screws through instrument 120into and through bone screw holes 82, 84 of plate 12. More particularly,portion 176 a of opening 176 and opening 152 are arranged such thatridge 177 guides a bone screw to bone screw opening 82 of plate 12,while portion 176 b of opening 176 and opening 152 are arranged suchthat ridge 177 guides a bone screw to bone screw opening 84 of plate 12.Further, cooperation of openings 154, 156 and openings 178, 180 allowsplacement of bone screws through instrument 120 into and through bonescrew holes 78, 80 of plate 12. More particularly, openings 154 and 178are generally arranged relative to instrument 120 to guide a bone screwto bone screw opening 80 of plate 12, while openings 156 and 180 aregenerally arranged relative to instrument 120 to guide a bone screw tobone screw opening 78 of plate 12. In addition, while not previouslydiscussed, it should be appreciated that cooperation of openings 152,176 may also facilitate engagement of receptacle 88 of retaining element86 to facilitate rotation of retaining element 86 following placement ofthe bone screws, although engagement of retaining element 86 byinserting an instrument along the length of instrument 120 throughhollow interior 160 is also contemplated. In addition, while notpreviously discussed, it should also be appreciated that the cooperationof openings 152, 176, openings 154, 178 and openings 156, 180 may alsofacilitate access to vertebral bodies V1, V2 with one or moreinstruments such as awls, drills or taps, just to provide a fewpossibilities, to prepare vertebral bodies V1, V2 for the bone screws.

Proximal end 170 of outer member 128 also includes an annular groove 182within which is positioned a retaining ring 184 in order to couple outermember 128 with drive member 130 such that drive member 130 isindependently rotatable relative to outer member 128. Drive member 130includes internal threading configured to engage with threaded proximalportion 132 of inner member 126. Similarly, rotation of drive member 130results in axial displacement of inner member 126 along longitudinalaxis L relative to outer member 128. A pin 186 extends from outer member128 into a slot 190 on inner member 126 to prevent rotation of innermember 126 relative to outer member 128. Further, a locking member 188extends through drive member 130 and is selectively engageable withinner member 126 to prevent rotation of drive member 130 relative toinner member 126 once a desired relationship between inner member 126and outer member 128 has been obtained. While not previously discussed,it should be appreciated that axial movement of inner member 126 alonglongitudinal axis L in a proximal direction relative to outer member 128results in engagement of distal end 172 of outer member 128 with taperedsurfaces 162, 164 of distal engaging portion 134 of inner member 126. Asdistal end 172 engages with tapered surfaces 162, 164, portions 148, 150and tines 136, 138 are forced toward one another. Moreover, axialmovement of inner member 126 along longitudinal axis L in a distaldirection relative to outer member 128 disengages distal end 172 ofouter member 128 from tapered surfaces 162, 164 to allow portions 148,150 and tines 136, 138 to be moved away from one another.

As indicated above, implant 10 and plate 12 are not coupled or otherwiseattached with one another. However, implant 10 and plate 12 can bepositioned adjacent one another with trailing end 22 of implant 10cooperating with surface 102 of plate 12. When implant 10 and plate 12are positioned in this arrangement, they may each be engaged byinstrument 120 as illustrated in FIG. 18 for example. More particularly,tine 136 can be positioned in groove 94 of plate 12 and in groove 57 ofimplant 10 with projection 140 positioned in receptacle 56 of implant 10and projection 142 positioned in receptacle 98 of plate 10. Similarly,tine 138 can be positioned in groove 92 of plate 12 and in groove 47 ofimplant 10 with projection 144 positioned in receptacle 46 of implant 10and projection 146 positioned in receptacle 96 of plate 10. Once tines136, 183 are engaged with implant 10 and plate 12, inner member 126 canbe moved proximally relative to outer member 128 to clamp implant 10 andplate 12 between tines 136, 138. Engagement of implant 10 and plate 12with instrument 120 generally holds implant 10 and plate 12 in acontiguous relationship. More particularly, engagement of projections140, 144 with receptacles 46, 56 of implant 10 and engagement ofprojections 142, 146 with receptacles 96, 98 of plate 10 preventsdisplacement of implant 10 from plate 12. However, once disengaged byinstrument 120, implant 10 may be displaced from plate 12.

While not previously discussed, it should be appreciated that thecircular configuration of receptacles 46, 56 and projections 140, 144,as well as the convex shape of trailing end 22 of implant 10 and thecorresponding concave shape of surface 102 of plate 12, allow implant 10to rotate relative to instrument 120 and plate 12 when it is engaged byinstrument 120. Further, the racetrack shaped configuration of grooves96, 98 and projections 142, 146 prevents rotation of plate 12 relativeto instrument 120 when it engages plate 12. In the illustrated form,rotation of implant 10 relative to plate 12 and instrument 120 will belimited in a first direction by contact of tine 136 with upper surface58 of groove 57 and of tine 138 with upper surface 48 of groove 47, andin a second direction by contact of tine 136 with lower surface 60 ofgroove 57 and of tine 138 with lower surface 50 of groove 47. Similarly,it should be appreciated that the orientation of upper and lowersurfaces 48, 50 relative to one another and of upper and lower surfaces58, 60 relative to one another can be modified to facilitate differingdegrees of rotation of implant 10 relative to plate 12 when they areengaged by instrument 120. In other forms however, it is contemplatedthat implant 10 can be configured such that its rotation relative toplate 12 is not limited.

When engaged by instrument 120, implant 10 and plate 12 can bepositioned relative to vertebral bodies V1, V2 together in a singlesurgical step. More particularly, leading end 20 of implant 12 can bepositioned in disc space D between vertebral bodies V1, V2 and advancedinto disc space D until bottom surface 88 of plate 12 contacts vertebralbodies V1, V2. As implant 10 is inserted and advanced into disc space D,it can rotate relative to plate 12 as necessary to accommodate for theorientation of vertebral bodies V1, V2 relative to disc space D. Forexample, when implant 10 and plate 12 are used in a curved or lordoticportion of the spinal column SC, implant 10 may extend obliquely asillustrated in FIG. 18, rather than orthogonally, to plate 12 once it isinserted in disc space D. Once implant 10 is properly positioned in discspace D and plate 12 is positioned against vertebral bodies V1, V2, bonescrews can be inserted through instrument 120 to attach plate 12 tovertebral bodies V1, V2, and retaining element 86 can be rotated toposition ends 86 a-d over the bone screws to prevent screw back-out.While only two bone screws have bone illustrated in FIG. 18, it shouldbe appreciated that plate 12 may be attached to vertebral bodies V1, V2with an upper pair of screws and a lower pair of screws. After thescrews have been inserted and covered by retaining element 86,instrument 120 may be disengaged from implant 10 and plate 12 andremoved from the surgical site.

An alternative embodiment insertion instrument 200 configured to engagewith implant 10 and plate 12 and position implant 10 and plate 12relative to vertebral bodies V1, V2 is illustrated in FIGS. 19-20.Instrument 200 extends along longitudinal axis LL from proximal end 202to distal end 204 and includes an inner member 206, outer member 208 anda drive member 210. Inner member 206 extends between a threaded proximalportion 212 and a distal engaging portion 214. Distal engaging portion214 is bifurcated into portions 216, 218 that form tines 220, 222.Portions 216, 218 also include tapered surfaces positioned proximally oftines 220, 222 and are laterally displaceable relative to one anothersuch that tines 220, 222 can be moved to facilitate engagement anddisengagement of instrument 200 with implant 10 and plate 12. Tine 220includes a distal, generally circular shaped projection 224 configuredto be positioned in receptacle 46 of implant 10. Tine 220 also includesa generally racetrack shaped projection 226 proximally spaced fromprojection 224 and configured to be positioned in receptacle 96 of plate12. Tine 220 is further configured to be positioned in groove 47 ofimplant 10 and groove 92 of plate 12 when instrument 200 is engaged withimplant 10 and plate 12. Tine 222 includes a distal, generally circularshaped projection 228 configured to be positioned in receptacle 56 ofimplant 10. Tine 222 also includes a generally racetrack shapedprojection 230 proximally spaced from projection 228 and configured tobe positioned in receptacle 98 of plate 12. Tine 222 is furtherconfigured to be positioned in groove 57 of implant 10 and groove 94 ofplate 12 when instrument 200 is engaged with implant 10 and plate 12.

Outer member 208 extends between proximal end 232 and distal end 234 andincludes a hollow interior within which inner member 206 is received.Distal end 234 also includes opposing tines 236, 238 which areconfigured to extend along and engage with lateral surfaces of tines220, 222. Outer member 208 also includes tapered surfaces positionedproximally of tines 236, 238 and configured to engage with the taperedsurfaces of inner member 206. Proximal end 232 of outer member 208 alsoincludes an annular groove within which is positioned a retaining ring240 in order to couple outer member 208 with drive member 210 such thatdrive member 210 is independently rotatable relative to outer member208. Drive member 210 includes internal threading configured to engagewith threaded proximal portion 212 of inner member 206. Similarly,rotation of drive member 210 results in axial displacement of innermember 206 along longitudinal axis L relative to outer member 208. A pin242 extends from outer member 208 into a slot on inner member 206 toprevent rotation of inner member 206 relative to outer member 208.Further, a locking member 244 extends through drive member 210 and isselectively engageable with inner member 206 to prevent rotation ofdrive member 210 relative to inner member 206 once a desiredrelationship between inner member 206 and outer member 208 has beenobtained. While not previously discussed, it should be appreciated thataxial movement of inner member 206 along longitudinal axis L in aproximal direction relative to outer member 208 results in engagement ofthe tapered surfaces of outer member 208 with the tapered surfaces ofinner member 206 which forces tines 220, 222 toward one another.Moreover, axial movement of inner member 206 along longitudinal axis Lin a distal direction relative to outer member 208 disengages thetapered surfaces of inner and outer members 206, 208 to allow portions216, 218 and tines 220, 222 to be moved away from one another.

When implant 10 and plate 12 are positioned adjacent one another asdiscussed above, they may each be engaged by instrument 200. Moreparticularly, tine 220 can be positioned in groove 94 of plate 12 and ingroove 57 of implant 10 with projection 224 positioned in receptacle 56of implant 10 and projection 226 positioned in receptacle 98 of plate10. Similarly, tine 222 can be positioned in groove 92 of plate 12 andin groove 47 of implant 10 with projection 228 positioned in receptacle46 of implant 10 and projection 230 positioned in receptacle 96 of plate10. Once tines 220, 222 are engaged with implant 10 and plate 12, innermember 206 can be moved proximally relative to outer member 208 to clampimplant 10 and plate 12 between tines 220, 222. Engagement of implant 10and plate 12 with instrument 200 generally holds implant 10 and plate 12in a contiguous relationship. More particularly, engagement ofprojections 224, 228 with receptacles 46, 56 of implant 10 andengagement of projections 226, 230 with receptacles 96, 98 of plate 10prevents displacement of implant 10 from plate 12. However, oncedisengaged by instrument 200, implant 10 is freely displaceable fromplate 12.

While not previously discussed, it should be appreciated that thecircular configuration of receptacles 46, 56 and projections 224, 228,as well as the convex shape of trailing end 22 of implant 10 and thecorresponding concave shape of surface 102 of plate 12, allows implant10 to rotate relative to instrument 200 and plate 12 when it is engagedby instrument 200. Further, the racetrack shaped configuration ofgrooves 96, 98 and projections 226, 230 prevents rotation of plate 12relative to instrument 200 when it engages plate 12. In the illustratedform, rotation of implant 10 relative to plate 12 and instrument 200will be limited in a first direction by contact of tine 220 with uppersurface 58 of groove 57 and of tine 222 with upper surface 48 of groove47, and in a second direction by contact of tine 220 with lower surface60 of groove 57 and of tine 222 with lower surface 50 of groove 47.Similarly, it should be appreciated that the orientation of upper andlower surfaces 48, 50 relative to one another and of upper and lowersurfaces 58, 60 relative to one another can be modified to facilitatediffering degrees of rotation of implant 10 relative to plate 12 whenthey are engaged by instrument 200. In other forms however, it iscontemplated that implant 10 can be configured such that its rotationrelative to plate 12 is not limited. When engaged by instrument 200,implant 10 and plate 12 can be positioned relative to vertebral bodiesV1, V2 together in a single surgical step, as discussed above inconnection with instrument 120. Once implant 10 and plate 12 arepositioned relative to vertebral bodies V1, V2, one or more instrumentsfor preparing vertebral bodies V1, V2 to receive bone screws can bepositioned between tines 220, 222 and through the bone screw holes 78,80, 82, 84 of plate 12, followed by insertion of the bone screws throughplate 12 from between tines 220, 222.

As discussed above, instruments 120, 200 can be used to engage andinsert implant 10 and plate 12 which is freestanding from implant 10;i.e., plate 12 is not mechanically attached or otherwise coupled toimplant 10. In this form, implant 10 and plate 12 are held adjacent toone another in a contiguous relationship by instruments 120, 200, butare otherwise freely displaceable to one another when not engaged byinstruments 120, 200. Further, engagement of implant 10 and plate 12with instruments 120, 200 allows implant 10 to be pivoted relative toplate 12, which is held stationary by instruments 120, 200, and toinstruments 120, 200 so that the orientation of implant 10 relative toplate 12 can be adjusted during implantation of implant 10 and plate 12.In other non-illustrated forms, it should be appreciated that theconfigurations of implant 10 and plate 12 can be reversed such thatplate 12 can be pivoted relative to implant 10, which is held stationaryby instruments 120, 200, and to instruments 120, 200 so that theorientation of plate 12 relative to implant 10 can be adjusted duringimplantation of implant 10 and plate 12. In other forms, it is alsocontemplated that instruments 120, 200 can be used to engage and insertan implant which is coupled to a plate. Moreover, while specific designsof implant 10 and plate 12 have been illustrated and described, itshould be appreciated that other designs of implant 10 and plate 12 alsofall within the scope of this disclosure.

In addition, while not previously discussed, it should be appreciatedthat implant 10 is generally centered on plate 12 when implant 10 andplate 12 are engaged by instruments 120, 200. Similarly, in thisarrangement, plate 12 will generally be centered relative to implant 10and the corresponding disc space into which implant 10 is insertedfollowing positioning of implant 10 and plate 12 with instruments 120,200 without any further manipulation or adjusting of plate 12. Amongstother things, the centering of plate 12 relative to implant 10 by thisarrangement results in bone screw holes 78, 80 and 82, 84 beingappropriately positioned relative to the endplates of the vertebraepositioned on opposite sides of the disc space to facilitate insertionof bone screws therethrough and into engagement with the vertebrae.Similarly, in certain aspects, given the proper placement of bone screwholes 78, 80 and 82, 84 relative to the adjacent vertebrae due to thecentering effect of plate 12 relative to implant 10 provided byinstruments 120, 200, plate 12 can be provided with a relatively smallerlength. However, in other aspects, it is contemplated that the length ofplate 12 is not adjusted due to this arrangement.

In one embodiment, a system for providing stabilization to first andsecond vertebrae includes an implant configured to be positioned betweenthe vertebrae and a plate configured to be positioned against andengaged with an exterior surface of each vertebra. The implant and platecan each be engaged by a single surgical instrument in an arrangementthat facilitates adjustment of the orientation of the implant and platerelative to one another during implantation of the implant and plate.Further, engagement of the implant and plate by the instrumentfacilitates implantation of the implant and plate together in a singlesurgical step without eliminating adjustability of implant relative tothe plate. In one aspect, the implant and plate are freestandingrelative to each other (i.e., the implant and plate are not coupled toone another) and the instrument holds the implant and plate in acontiguous relationship when it is engaged therewith.

While not previously discussed, it should be appreciated that, unlessotherwise described, the implants, devices, and instruments describedherein may be made from any suitable biocompatible material, includingbut not limited to titanium, titanium alloy, stainless steel, metallicalloys, polyaryletherketone (PAEK), polyetheretherketone (PEEK),carbon-reinforced PEEK, polyetherketoneketone (PEKK), polysulfone,polyetherimide, polyimide, ultra-high molecular weight polyethylene(UHMWPE), and plastics, just to name a few possibilities. The implantsand plates can be made from the same material, or of different material.Of course, it is understood that the relative size of the components canbe modified for the particular vertebra(e) to be instrumented and forthe particular location or structure of the vertebrae relative to whichthe implant and plate will be positioned.

Further, it should also be appreciated that the implants, instruments,devices, systems, techniques and methods described herein may also beused in surgical procedures involving animals, or in demonstrations fortraining, education, marketing, sales and/or advertising purposes.Furthermore, the implants, instruments, devices, systems, techniques andmethods described herein may also be used on or in connection with anon-living subject such as a cadaver, training aid or model, or inconnection with testing of surgical systems, surgical procedures,orthopedic devices and/or apparatus.

Any theory, mechanism of operation, proof, or finding stated herein ismeant to further enhance understanding of the present application and isnot intended to make the present application in any way dependent uponsuch theory, mechanism of operation, proof, or finding. It should beunderstood that while the use of the word preferable, preferably orpreferred in the description above indicates that the feature sodescribed may be more desirable, it nonetheless may not be necessary andembodiments lacking the same may be contemplated as within the scope ofthe application, that scope being defined by the claims that follow. Inreading the claims it is intended that when words/phrases such as “a”,“an”, “at least one”, and/or “at least a portion” are used, there is nointention to limit the claim to only one item unless specifically statedto the contrary in the claim. Further, when the language “at least aportion” and/or “a portion” is used, the item may include a portionand/or the entire item unless specifically stated to the contrary.

While the application has been illustrated and described in detail inthe drawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the selected embodiments have been shown and described and that allchanges, modifications and equivalents that come within the spirit ofthe application as defined herein or by any of the following claims aredesired to be protected.

What is claimed is:
 1. A method for providing spinal stabilization,comprising: engaging an implant and a plate with an insertion instrumentto retain the implant and the plate in a contiguous, uncoupledarrangement; inserting a leading end of the implant in a spinal discspace between first and second vertebrae with the insertion instrument;and advancing the implant into the disc space with the insertioninstrument until a bottom surface of the plate contacts extradiscalsurfaces of the vertebrae.
 2. A method as recited in claim 1, whereinthe inserting and the advancing are part of a single surgical step.
 3. Amethod as recited in claim 1, wherein the disc space is accessed from ananterior approach.
 4. A method as recited in claim 1, wherein engagingthe implant and the plate with the insertion instrument comprisesinserting a tine of the insertion instrument into a groove of the plateand a groove of the implant.
 5. A method as recited in claim 1, whereinengaging the implant and the plate with the insertion instrumentcomprises inserting tines of the insertion instrument into grooves ofthe plate and grooves of the implant.
 6. A method as recited in claim 1,further comprising rotating the implant relative to the plate when theinsertion instrument is engaged with the implant and the plate.
 7. Amethod as recited in claim 1, further comprising rotating the implantrelative to the plate when the implant and the plate are retained in thecontiguous, uncoupled arrangement by the insertion instrument.
 8. Amethod as recited in claim 7, wherein engaging the implant and the platewith the insertion instrument comprises inserting racetrack shapeprojections of the insertion instrument into racetrack shape grooves ofthe plate to prevent rotation of the plate relative to the insertioninstrument.
 9. A method as recited in claim 1, wherein: engaging theimplant and the plate with the insertion instrument comprises insertingcircular projections of the insertion instrument into circularreceptacles of the implant; and the method further comprises rotatingthe implant relative to the plate when the implant and the plate areretained in the contiguous, uncoupled arrangement.
 10. A method asrecited in claim 9, wherein engaging the implant and the plate with theinsertion instrument comprises inserting racetrack shape projections ofthe insertion instrument into racetrack shape grooves of the plate toprevent rotation of the plate relative to the insertion instrument. 11.A method as recited in claim 9, wherein the implant comprises a convextrailing end that faces a concave surface of the plate to facilitaterotation of the implant relative to the plate.
 12. A method as recitedin claim 1, wherein engaging the implant and the plate with theinsertion instrument comprises inserting racetrack shape projections ofthe insertion instrument into racetrack shape grooves of the plate toprevent rotation of the plate relative to the insertion instrument. 13.A method as recited in claim 1, wherein engaging the implant and theplate with the insertion instrument comprises inserting racetrack shapeprojections of the insertion instrument into racetrack shape grooves ofthe plate to prevent rotation of the plate relative to the insertioninstrument and inserting circular projections of the insertioninstrument into circular receptacles of the implant to allow rotation ofthe implant relative to the plate.
 14. A method as recited in claim 1,wherein no portion of the plate is positioned within the disc space whenthe bottom surface of the plate contacts the extradiscal surfaces of thevertebrae.
 15. A method for providing spinal stabilization, comprising:engaging an implant and a plate with an insertion instrument to retainthe implant and the plate in a contiguous, uncoupled arrangement;rotating the implant relative to the plate; inserting a leading end ofthe implant in a spinal disc space between first and second vertebraewith the insertion instrument; advancing the implant into the disc spacewith the insertion instrument until a bottom surface of the platecontacts extradiscal surfaces of the vertebrae; and inserting bonescrews through the plate and into the vertebrae.
 16. A method as recitedin claim 15, wherein engaging the implant and the plate with theinsertion instrument comprises inserting racetrack shape projections ofthe insertion instrument into racetrack shape grooves of the plate toprevent rotation of the plate relative to the insertion instrument. 17.A method as recited in claim 16, wherein engaging the implant and theplate with the insertion instrument comprises inserting circularprojections of the insertion instrument into circular receptacles of theimplant to allow rotation of the implant relative to the plate.
 18. Amethod as recited in claim 15, wherein engaging the implant and theplate with the insertion instrument comprises inserting tines of theinsertion instrument into grooves of the plate and grooves of theimplant.
 19. A method as recited in claim 15, wherein no portion of theplate is positioned within the disc space when the bottom surface of theplate contacts the extradiscal surfaces of the vertebrae.
 20. A methodfor providing spinal stabilization, comprising: engaging an implant anda plate with an insertion instrument to retain the implant and the platein a contiguous, uncoupled arrangement; rotating the implant relative tothe plate; inserting a leading end of the implant in a spinal disc spacebetween first and second vertebrae with the insertion instrument;advancing the implant into the disc space with the insertion instrumentuntil a bottom surface of the plate contacts extradiscal surfaces of thevertebrae and no portion of the plate is positioned within the discspace; inserting bone screws through holes in the plate and into thevertebrae; and rotating a retaining element of the plate comprising aplurality of arms separated by gaps from a first position in which thegaps are aligned with the holes to a second position in which the armsoverlap the holes to prevent the bone screws from backing out of theholes.